Medtronic recalls specific CRT-P MRI devices due to software overestimating device lifespan. Affected models have serial numbers starting with W1TR or W4TR. No immediate action needed but check your device.
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Medtronic is recalling certain CRT-P MRI devices that may show a longer lifespan than actual due to a software issue. This could lead to premature device replacement if the device triggers earlier than expected.
The software overestimates the device's lifespan by about 6 months before it triggers the recommended replacement time. This means the device might need replacement sooner than expected, potentially causing issues with heart rhythm treatment.
Patients with Medtronic CRT-P MRI devices, particularly those with specific serial numbers starting with W1TR or W4TR. Those who have the device implanted for arrhythmia treatment are most at risk.
Check your device's serial number, which starts with W1TR or W4TR for Percepta or Serena models. The devices are used for arrhythmia treatment and cardiac resynchronization therapy.
Look for serial numbers starting with W1TR or W4TR on your CRT-P MRI device.
No immediate action is required, but you should check your device's serial number to see if it is affected.
The device may trigger replacement earlier than expected, so it's important to monitor your device's status.
Check your device's serial number, which starts with W1TR or W4TR for Percepta or Serena models.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1523-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1523-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
